Compendial Testing

Geneva Laboratories’ chemistry department provides quality compendial and non-compendial chemical analysis of raw materials and final product. Compendial testing of pharmaceuticals (APIs and drug products), food additives, and reagent chemicals is performed under one of the following compendia:

United States Pharmacopoeia/National Formulary

European Pharmacopoeia

Japanese Pharmacopoeia

Food Chemicals Codex

American Chemical Society Reagent Chemicals, 10th edition

Geneva Laboratories is DEA registered for handling Class II, Class III, and Class IV controlled substances. While most testing is performed according to USP monographs, we can develop and validate methods for controlled actives and the drug products made with them. Recent samples of controlled substances have included opiates, benzodiazepines, and anabolic steroids.

Method Development/Validation

Method Development/Validation services are offered for residual solvents testing for individual APIs and drug products, API and preservative assays in drug products, and impurities in APIs and drug products. These services are also offered for materials and/or testing requirements that are not covered by compendia specifications.

Validation of methods developed by Geneva Laboratories is performed according to the requirements in USP general chapter <1225>. Validation studies include determination of the linearity, range, accuracy, repeatability, and intermediate precision of the method. For residual solvents and impurities methods, validation also includes determination of the limit of detection and the limit of quantitation.

Ethylene Oxide Residuals

Geneva Laboratories is able to test for EO sterilization residuals in medical devices for both FDA (ppm limits) and ISO 10993-7 compliance. Headspace and water extraction methods can be run depending on the device category. Note that headspace extraction can only be used for EO, not ECH or EG, as their boiling points are too high for headspace sampling to be effective.

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Our Mission

Geneva Laboratories, Inc. seeks to provide testing services that promote patient well-being while certifying patient safety by offering accurate, reliable and cost-effective testing to the medical industry and building long-term relationships with our testing sponsors based on trust and service.